krause



April 14, 1964 l. J. KRAUSE 3,128,917

DEVICE FOR PERENTERAL SOLUTIONS Filed July 26, 1960 2 Sheets-Sheet lInventor Ir a Jag, Krause April 14, 1964 l. J. KRAUSE 3,128,917

DEVICE FOR PERENTERAL SOLUTIONS Filed July 26. 1960 2 Sheets-Sheet 2Invenlox Ira Jag Krause fl-flzomzg lOl United States Patent Ofiice3,128,917 Patented Apr. 14, 1964 3,128,?17 DEVICE FUR PARENTERALSULIJ'IHONE'I Ira .lay Krause, Winthrop Harbor, Iil., assignor to AbbottLaboratories, North Chicago, Ill., a corporation oi Illinois Filed July26, 196i), Ser. No. 45,402 2 Claims. (Cl. 222-190) This inventionrelates to a device for the administration of parenteral liquids. Moreparticularly, this invention is concerned with a combined storage,mixing and dispensing means for sterile medicaments from which sterilesolutions are prepared.

In the administration of parenteral solutions, it is standard practiceto prepare the solutions from sterile powders or liquids immediatelybefore administration. This must be done because of the instability ofmost medicaments when placed in solution. It is common procedure inpreparing relatively large quantities of parenteral solutions, such as avolume of 500 cc., to supply a sterile medicament in a separatecontainer and sterile water in another. This procedure poses manyproblems sterilitywise in the transferring of the medicament into thecontainer of sterile water. ment is contained in an ampoule, the ampoulemust be broken with the chance that small particles of broken glass willfall into the medicament or into the bottle of water. Also, where anampoule is employed, the operators fingers can easily come into contactwith the surfaces of the ampoule or the bottle into which the medicamentis poured. In the instance of a medicament in powder form, if it shouldtend to adhere to the interior of the ampoule, or the container in whichit is stored, it will have to be washed therefrom or removed in someother manner it full and accurate dosages are to be obtained and themedicament not wasted.

Once the solution is composed, some sort of dispensing apparatus must beemployed in order to administer the solution. This necessitates thehandling of another piece of apparatus with the further danger thatcontamination can occur when the apparatus is connected to the bottle.

It is therefore an object of the present invention to provide a singleunit, storing, mixing and dispensing device for parenteral solutionwhich substantially reduces contamination of the sterile solution.

It is another object of the present invention to provide a sterile meansfor storing and mixing sterile powders and liquids, and dispensingsterile solutions formed therefrom, without any waste of the medicamentand insuring accurate dosages thereof.

It is a further object of the present invention to provide a device forstoring, mixing and dispensing solutions of sterile powders in which thedevice is of a single unit construction and is economical tomanufacture.

Other objects of the present invention will be apparent from the detaildescription and claims to follow.

In the drawing:

FIGURE 1 is a view in side elevation of the present inventionoperatively mounted on a solution bottle at one end having a hypodermicsyringe engaged at the other end.

FIGURE 2 is an enlarged view in side elevation and partially in verticalsection of the novel device of this invention with sealing caps placedthereon.

FIGURE 3 is a top plan view of the device shown in FIGURE 2 with thesealing cap removed therefrom.

FIGURE 4 is a fragmentary view of the device shown in FIGURE 2,partially in vertical section, and in pouring contact with a solutionbottle.

FIGURE 5 is a view in side elevation and partially in vertical sectionof an alternative embodiment of this invention.

For example, where the medica- FIGURE 6 is an enlarged view in verticalsection of another alternative embodiment of this invention.

The device of the present invention, as shown in FIG- URE 1, isoperatively mounted on a glass solution container 10 containing aparenteral solution, having external threads 11 on neck 12. The deviceshown generally at 13 is comprised of a cylindrical body section 14having an open end 15a and having a cylindrical skirt or wall 15 withinternal threads 16 which engage threads 11 on the container iii. Thebody section 14 is preferably formed of a stable plastic material suchas polyethylene.

Securedly attached to body section 14 is a cylindrical storagecompartment 17 which in this instance is formed from glass. At the endopposite body section 14, an end closure 18 is provided on compartment17 for engagement with a hypodermic syringe 19. End closure 18 is formedof the same material as body section 14. Molded integrally in end wall2% of body section 14 is a tubular air vent 21. Referring to FIGURE 2,it will be seen that air vent 21 has a passageway 22 communicating withthe inside of body section 14. Over the outer end of passageway 22 isplaced a valve means 23 which has a cylindrical skirt 24 and a shoulderportion 25 for engagement with the end of tubular vent 21. Valve means23 has a passageway 26 placed in alignment with passageway 22 of ventZ1. Disposed transversely across passageway 22 is a liquid imperviousbarrier of fibers 27 that are pervious to air. The types of fibersemployed in this instance are described in U.S. Patent 2,775,240.

Extending outwardly from end wall 20 of body section 14 and spaced in aparallel manner from air vent 21 is a tubular portion 28 having alocking portion 29' defined by two circumferential grooves 29 and 30therein. Grooves 29 and 3d accommodate a mating locking portion 31'defined by circumferential rings 31 and 32, respectively, formed on theconstricted neck portion 33 of storage compartment 17. The upper openend 33a of neck portion 33 abuts against the outer edge of end wall 255and a fluid-tight engagement is thereby formed between body section 14and compartment 17. Through end wall Zti an opening 34 is formed. Formedintegrally with end wall it) adjacent opening 34 is a semi-circularpouring lip 35 which extends upwardly from the end wall 20. This is bestillustrated in FIGURE 3. Since the pouring lip 35 surrounds only aportion of the opening 34, the powder is able to be observed as it isbeing poured over the pouring lip 35.

End closure 18 is secured to a second opposing neck portion 36 ofcompartment 17 in the same manner as neck portion 33 is attached to thetubular porton 28. Two circumferential grooves 37 and 33 disposed in theinside of the U-shaped wall section 39 of closure 18 accommodate twocircumferential rings 40 and 41, respectively, of neck portion 36. Adischarge passage 42 extends through closure 18, the outer portion ofwhich is provided with an inwardly Luer tapering surface 43. Passage 42is sealed in a closed manner by means of a Passage 42 is sealed in aclosed manner by means of cylindrical plug 44 having a skirt portion 45and a stepped projection 46 which extends into passage 42.

Sterile powder 47 is stored in compartment 17 and is retained therein bymeans of plug 44 at one end and a downwardly depending stopper 48 at theother. Stopper id is molded integrally with sealing cap 49 which alsoprevents contamination of the interior of body section 14.

In operation, sealing cap 49 with stopper 48 is removed and storagecompartment 17 is filled under sterile conditions with sterile powder47. Sealing cap 49 is then secured on body section 14 with stopper 48disposed in sealing engagement with neck portion 33. The unit is thenready for shipment and storage. When it is desired to compose a solutionof powder 47 for parenteral administration, cap 49 with stopper 48, isremoved and semicircular pouring lip 35 is placed in contact with themouth of bottle 10 as shown in FIGURE 4. Sterile powder 47 flows outthrough constricted neck portion 33 of compartment 17 onto lip 35 andinto the container 1'1) containing a sterile liquid. If desired, andshould powder 47 tend to adhere to the interior of compartment 17, bodysection 14 can be screwed onto the container 19 as shown in FIGURE 1 andthe novel device 13 inverted with the container 10. In this position,the liquid from the container 10 will flow into compartment 17. Withdevice 13 attached to the container 18, further dissolving of powder 47can be effected by shaking the attached units in an appropriate manner.When powder 4-7 is completely dissolved, the container 10 is placed inan upright position and plug 44 is removed from end closure 18.Hypodermic syringe 19 having a Luer taper 49 at the outer end thereof,and without a needle, is inserted into tapering surface 42 of endclosure 18. Tie container 10 is then inverted and the sterile solutioncontaining powder 47 is drawn into syringe 19 by manipulating syringe 19in a normal manner, as illustrated in FIGURE 1. Solution flows out ofthe container 19 through the opening 34 and compartment 17 and intosyringe 19. To replace the volume of solution withdrawn, air travelsthrough air vent 21 and into container 10. After withdrawing apredetermined volume of solution, bottle 10 is returned to an uprightposition, syringe 19 is removed and plug 4 is replaced in end closure18.

An alternative embodiment 60 of the present invention is illustrated inFIGURE having a cylindrical body section 61 and an end wall 62 composedof the same materials as body section 14. Internal threaded portion 63is provided in the inside of body section 61. Disposed through end wall62 are air vent 64 with valve means 65 and discharge passageway 66 withclosure plug 67. For all practical purposes, air vent 64 with valvemeans 65 and passageway 66 are of the same construction as air vent 21with valve means 23 and discharge passageway 42, respectively. A reduceddiameter storage portion, which is shown to be a cylindrical glassinsert 63, is placed inside cylindrical wall portion 69 of body section61 and extends from the inside of end wall 62 to a point a shortdistance below screw threads 63. A sealing ring 7t) which isaccommodated in wall portion 69 by groove 79 is placed over the end ofinsert 68 and thereby holds the insert in place. It will be seen thatwall portions 69 and 62 along with glass insert 68 form a compartmentsimilar to compartment 17 for sterile powder 71. A sealing cap 72 withintegral plug 73 is provided for the same purpose as that describedpreviously for sealing cap 49 and stopper 48 in embodiment 13. Thealternative device 69 likewise operates in substantially the same manneras that described for the unit in FIGURES 1-4.

FIGURE 6 illustrates a further alternative embodiment 80 of thisinvention, somewhat similar to that of device 13, having a cylindricalbody section 81 with skirt 82 and internal threads 83. Body section 81like body section 14 of device 13 is formed of plasticized polyethylene.

End wall 84 has a tubular passageway 35 formed by an upwardly extendingtubular portion 86 and a down wardly extending tubular portion 87.Integrally molded in the tubular portion 87 is air vent 88 with valvemeans 89 which are exact duplicates of air vent 21 and valve means 23 ofdevice 13. The tubular portion 87 is provided with a locking portion 90defined by circumferential grooves 90 and 91 to accommodate a matinglocking portion 92' defined by circumferential rings 92 and 93,respectively, of glass compartment 94 and serves as a secure means ofattachment. Secured to the end of compartment 94 is end closure 95having circumferential grooves 96 and 97 for accommodatingcircumferential rings 98 and 99, respectively. A discharge passage 199is provided in end closure 95 having a resealable closure piug 1 11which is pierceable with the needle (not shown) of a hypodermic syringeas basically shown in FIGURE 1.

Compartment 94 contains sterile powder 102 retained therein by means ofplug 191 as well as plug 103 which is molded in cover cap 104.

Embodiment 30 is operated in substantially the same manner as thatdescribed for the device in FIGURES 1-4 with the exception that a smoothpouring surface is formed in passageway by the tubular portions 86 andS7. The tubular portion 86, at a point opposite air vent 88, therebyserves as a pouring lip. A further exception is that a syringe, similarto 19 but having a hypodermic needle, is employed to withdraw thedesired amount of solution.

While body sections 14, 61 and 81 have been described as being composedof a plastic material such as polyethylene, it should be understood thatother plastics and other materials can be used such as nylon,polystyrenes, polyvinylchloride, rubber and glass. Instead of formingcompartments 17 and 94 of glass which in some instances is necessarybecause of the instability of some medicinal powders, it could be formedas an integral part of the cap and of the same material.

The embodiments of this invention have been described for use withpowders which are ultimately mixed into solutions. It should beunderstood that lyopholized materials or liquids could likewise beemployed in place of the powder in compartments 17 and 94 as well as thecomparable compartment formed in alternative device 60. The mixingprocedure would be the same as that described for the powder.

It will thus be seen that applicant has provided a compact device formixing and dispensing sterile solutions wherein the same device alsoserves as a storage and shipping container for unstable sterile powdersor liquids. Also, the novel device serves as a closure means, oncemixing is completed. All of the foregoing functions are accomplished bya single unit apparatus with the sterility of the powder or liquid, aswell as the consequent solution formed, being maintained at all times.It should also be observed that by withdrawing the solution through thestorage compartment, complete mixing of the powder or liquid is effectedwhich insures the administration of accurate doses and prevents waste ofthe medicament.

Others can practice the invention in any of the numerous ways which willbe suggested by this disclosure to one skilled in the art. All suchpractice of the invention is considered to be a part hereof provided itfalls within the scope of the appended claims.

Iclaim:

1. A device for the sterile storing and mixing of medicinal powders, andfor the dispensing of parenteral solutions formed therefrom comprisingin combination: a plastic, cylindrical body section having an end walland a skirt portion with internal threads at the outer end thereof toform a fluid-tight, detachable connection with the outlet of a fluidcontainer; a cylindrical glass insert, the external diameter of which isapproximately the same as the internal diameter of said skirt portion,said insert resting against said end wall at one end and extending to apoint a short distance below said threads; an internal groove in saidskirt portion accommodating a ring therein, said ring contacting theother end of said insert and holding said insert securely in said bodysection; a plug in sealing engagement with the inside of said insert; asealing cap detachably secured to the outer surface of said skirtportion until such time as said device is attached to said outlet ofsaid fluid container to protect the interior of said body sectionagainst contamination, said sealing cap being integrally attached tosaid sealing plug, said sealing plug and said insert with said end wallforming a storage compartment partially filled with said medicinalpowders in said body section; an air vent with valve means associatedtherewith communicating with the interior of said body section throughsaid end wall; a liquid discharge passage in said end wall spaced in aparallel manner with said air vent; said passage having at the outer endthereof an inwardly tapering surface adapted to receive in sealingengagement a hypodermic syringe hub; and a sealing plug mounted on saidend closure in the absence of said huh.

2. A device for the sterile storing and mixing of medicinal powders, andfor the dispensing of parenteral solutions formed therefrom comprisingin combination: a plastic body section with an end wall and a skirtportion extending from said end wall with internal threads to form afluid-tight, detachable connection with the external threads of a fluidcontainer; a sealing cap detachably secured to the outer surface of saidbody section until such time as said device is attached to said outletof said fluid container to protect said body section againstcontamination; a passageway extending through said end wall; a glass,tubular storage compartment partially filled with said medicinalpowders, one end of said compartment in fluid-tight engagement with saidpassageway, said tubular storage compartment being of substantiallygreater diameter than said passageway; a tubular air vent with valvemeans associated therewith extending transversely in an outward mannerfrom said end wall and parallel to said passageway; a semi-circularpouring lip adjacent said passageway and extending inwardly from saidend wall, said pouring lip positioned between said passageway and saidair vent; a plug in sealing engagement in said passageway and extendinga short distance inwardly into said compartment, said plug beingintegrally attached to said sealing cap; an end closure for said storagecompartment at the other end thereof, having a liquid discharge passagetherethrough, said passage having at the outer end thereof an inwardlytapering surface adapted to receive a hypodermic syringe hub; and asealing plug mounted on said end closure in the absence of said hub.

References Cited in the file of this patent UNITED STATES PATENTS225,440 Vasseur Mar. 9, 1880 318,637 Marshall May 26, 1885 2,455,645Barton Dec. 7, 1948 2,626,730 Gabler Ian. 27, 1953 2,775,240 Morrisey etal. Dec. 25, 1956 2,812,117 Butkus et al. Nov. 5, 1957 2,852,024 RyanSept. 16, 1958 2,966,282 Geisler Dec. 27, 1960 3,001,525 Hendricks Sept.26, 1961 FOREIGN PATENTS 817,097 Germany Oct. 15, 1951

1. A DEVICE FOR THE STERILE STORING AND MIXING OF MEDICINAL POWDERS, ANDFOR THE DISPENSING OF PARENTERAL SOLUTIONS FORMED THEREFROM COMPRISINGIN COMBINATION: A PLASTIC, CYLINDRICAL BODY SECTION HAVING AN END WALLAND A SKIRT PORTION WITH INTERNAL THREADS AT THE OUTER END THEREOF TOFORM A FLUID-TIGHT, DETACHABLE CONNECTION WITH THE OUTLET OF A FLUIDCONTAINER; A CYLINDRICAL GLASS INSERT, THE EXTERNAL DIAMETER OF WHICH ISAPPROXIMATELY THE SAME AS THE INTERNAL DIAMETER OF SAID SKIRT PORTION,SAID INSERT RESTING AGAINST SAID END WALL AT ONE END AND EXTENDING TO APOINT A SHORT DISTANCE BELOW SAID THREADS; AN INTERNAL GROOVE IN SAIDSKIRT PORTION ACCOMODATING A RING THEREIN, SAID RING CONTCTING THE OTHEREND OF SAID INSERT AND HOLDING SAID INSERT SECURELY IN SAID BODYSECTION; A PLUG ION SEALING ENGAGEMENT WITH THE INSIDE OF SAID INSERT; ASEALING CAP DETACHABLY SECURED TO THE OUTER SURFACE OF SAID SKIRTPORTION UNTIL SUCH TIME AS SAID DEVICE IS ATTACHED TO SAID OUTLET OFSAID FLUID CONTAINER TO PROTECT THE INTERIOR OF SAID BODY SECITONAGIANST CONTAMINATION, SAID SEALIANG CAP BEING INTEGRALLY ATTACHED TOSAID SCALING PLUG, SAID SEALING PLUG AND SAID INSERT WITH SAID END WALLFORMING A STORAGE COMPARTMENT PARTIALLY FILLED WITH SAID MEDICINALPOWDERS IN SAID BODY SECTION; AN AIR VENT WITH VALVE MEANS ASSOCIATEDTHERE WITH COMMUNICATING WITH THE INTERIOR OF SAID BODY SECTION THROUGHSAID END WALL; A LIQUID DISCHARGE PASSAGE IN SAID END WALL SPACED IN APARALLEL MANNER WITH SAID AIR VENT; SAID PASSAGE HAVING AT THE OUTER ENDTHEREOF AN INWARDLY TAPERING SURFACE ADAPTED TO RECEIVE IN SEALINGENGAGEMENT A HYPODERMIC SYRINGE HUB; AND A SEALING PLUG MOUNTED ON SAIDEND CLOSURE IN THE ABSENCE OF SAID HUB.